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EC number: 210-379-6 | CAS number: 614-33-5
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerol tribenzoate
- EC Number:
- 210-379-6
- EC Name:
- Glycerol tribenzoate
- Cas Number:
- 614-33-5
- Molecular formula:
- C24H20O6
- IUPAC Name:
- 1,3-bis(benzoyloxy)propan-2-yl benzoate
- Test material form:
- solid: flakes
- Details on test material:
- room temperature: off-white coloured flakes or granulate; > 80 °C: colourless to yellowish liquid
Batch no. 20118
CAS no. 614-33-5
Production date 28. Jul. 2020
Expiry date 15. Aug. 2022
Constituent 1
- Specific details on test material used for the study:
- Batch no. 20118
Expiry date 15. Aug. 2022
Purity 98.1%
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
Note: each batch of S9 is characterized with a mutagen that requires metabolic activation by microsomal enzymes (e.g., benzo(a)pyrene).Note: each batch of S9 is characterized with a mutagen that requires metabolic activation by microsomal enzymes (e.g., benzo(a)pyrene). - Test concentrations with justification for top dose:
- Experiment 1 Test item concentrations: 5000, 1500, 500, 150, 50 µg/plate
Experiment 1b Test item concentrations: 5000, 1500, 500, 150, 50 µg/plate
Experiment 2 Test item concentrations: 5000, 2500, 1250, 625, 313, 156, 78 µg/plate
On the day of the start of the first experiment, a stock solution containing 50 g/L of the test item in DMSO was prepared.
The stock solution was used to prepare the geometric series of the concentrations to be tested. The following nominal test item concentrations were prepared for experiment 1:
5000, 1500, 500, 150 and 50 µg/plate.
On the day of the start of the second experiment, a stock solution containing 50 g/L of the test item in DMSO was prepared.
The following nominal test item concentrations were prepared for experiment 2:
5000, 2500, 1250, 625, 313,156, 78 µg/plate. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine, 2-Amino-anthracene,
- Details on test system and experimental conditions:
- 6.2.2 Origin and Culture
All Salmonella typhimurium strains were obtained from Trinova BioChem GmbH (batch: TA98: 5465D, TA100: 5439D, TA102: 5420D, TA1535: 5484D, TA1537: 5450D) and were stored as lyophilizates in the refrigerator at 2 – 8 °C.
On the day before the start of each experiment, a nutrient broth (Oxoid nutrient broth no. 2) was inoculated with one lyophilizate per strain at 3:30 pm (exp. 1) and 3:20 pm (exp. 1b and 2).
These overnight cultures were placed in the heating chamber at 37 ± 1 °C for 16 hours and 30 min. (exp. 1) and 16 hours and 40 min. (exp. 1b and 2).
For the last two hours the overnight cultures were shaken on an orbital shaker (150 rpm) at 37 ± 1 °C.
Afterwards, the overnight cultures were ready for use in the experiment.
During the test, the overnight cultures were stored at room temperature (20 ± 5 °C) to prevent changes in the titre.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
For TA102, the experiment 1 was invalid, since the spontaneous revertants were higher than historical control data and the f(I) values of the positive controls were not > 2 in the presence and absence of metabolic activation.
The experiment was repeated for TA102 as experiment 1b and was valid.
The test item showed no precipitates andno signs of toxicity towards the bacteria strainson the plates at any of the concentrationsin boththe presence and the absence of metabolic activation in all evaluated experiments.
The results of all experiments showed that none of the tested concentrations showed a significant increase or dose-related increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
Based on the results of this study it is concluded thatGlycerol tribenzoate (GTB)is not mutagenic in theSalmonella typhimuriumstrains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation under the experimental conditions in this study.
Applicant's summary and conclusion
- Executive summary:
Based on the results of this study it is concluded thatGlycerol tribenzoate (GTB)is not mutagenic in theSalmonella typhimuriumstrains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation under the experimental conditions in this study.
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